BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OE-A65

    Reg #: 3010772972 · FEI: 3010772972 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHI-ATEX CO.,LTD
    Registration Number
    3010772972
    FEI Number
    3010772972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-3 Ozushima-cho
    City
    Izumiotsu Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K202365

    Owner / Operator

    Firm Name
    SHI-ATEX Co.,Ltd
    Operator Number
    10045205
    Address
    5-3 Ozushima-cho
    City
    Izumiotsu
    State
    Osaka
    Postal Code
    5950074
    Country
    JP

    US Agent

    Business Name
    Ken Block Consulting
    Contact Name
    Kenneth Block
    Address
    3400 N Central Expy Ste 110265
    City
    Richardson
    State
    TX
    ZIP
    75080
    Country
    US
    Email
    [email protected]
    Phone
    972 4809554

    Products

    Device Name Product Code
    Duodenoscope And Accessories, Flexible/Rigid FDT

    Proprietary Names

    OE-A65

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)